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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Food and Drug Administration (FDA) has announced its plans to study whether consumers would benefit if direct-to-consumer television advertising contained a shorter list of major side effects instead of the now-lengthy list of nearly all of them.

Background

The study, first proposed in February 2014, is meant to address a regulatory hypothesis: That consumers, bombarded with a long list of side effects, might have a difficult time deciding between drugs. In the same vein, patients might also avoid potentially beneficial or even life-saving therapy if they believe a drug is riskier than it actually is.

As FDA explains in a new Federal Register notice: "There is concern that as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects."

FDA's proposal calls for a shift in how risk information is presented to consumers. Instead of companies needing to devote equal time to both the benefits and risks of a drug product—known as FDA's "fair balance" doctrine—the agency would instead permit companies to list only the side effects contained in a drug's "major statement," which contains the product's most prominent risks.

FDA said this proposal would ensure that patients are given risk information that is "serious and actionable."

In addition to the major statements, drug ads would also be required to include a statement about where consumers can find out more information about the full list of drug risks and side effects.

FDA said one possible disclosure statement might read: "This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for more information.”

Study Announced

But whatever the hypothetical merits of the proposal, FDA said it's not yet ready for primetime.

First, the agency says it plans to "investigate the effectiveness" of what's it's calling the "limited risks plus disclosure strategy" using a study.

Its proposed study will involve patients 18 years or older who self-identify as having been diagnosed with depression, high cholesterol or insomnia. Those patients will view one of four versions of a DTC advertisement, each with various disclosures of risk.

Interestingly, FDA says it plans to modify an advertisement already in the marketplace—a plan industry group PhRMA panned in its comments to the agency. However, FDA said the existing ad would be considerably cheaper for it to use, and that it would not fictionalize any of the drug's risks.

FDA says it plans to include 600 participants in a pilot study, and another 1,500 participants in the main study.